Acurx Pharmaceuticals (NASDAQ: ACXP) shares continue to rally following last week's IPO. Shares are trading at $6.91 on Tuesday, more than 15% higher than its IPO offering price. Notably, investors took the post-IPO price to $8.74 before settling back to close at $7.89. And while shares may be off that high, a low share count of only about 9.5 million shares combined with strong investor interest could send prices back toward those levels sooner rather than later. (*stock price of $6.91 at 12:18 est 6/29/21)
Even better, with ACXP intending to deliver the first new class of antibiotics since the 1980s, they could earn a substantial interest from industry players wanting a sneak-peek at their portfolio. And with an advancing Phase 2b trial, don't rule out an early partnership or licensing opportunity.
Indeed, Acurx could very well be "in-play." They already have an ongoing Phase 2b clinical trial evaluating the benefits of ibezapolstat as a front-line treatment for C. difficile (CDI), a debilitating germ that causes severe diarrhea and colitis. Further, they are advancing preclinical development for potential new antibiotic candidates in scientific collaboration with WuXi AppTec and in the late-stage processes of completing manufacturing and formulation of ACX-375C to treat Gram-positive infections. Moreover, ACXP is advancing its CCP1 program through the discovery phase to develop multiple product candidates to treat various gram-positive infections. Thus, investor interest is warranted.
Better still, for investors wanting near-term excitement, ACXP is expected to deliver trial updates before the end of this year. Thus, while its 15% gains are impressive, the back half of this year could provide substantially more.
Encouraging Data Targeting Gram-Positive Bacteria
In fact, ACXP is positioned to do just that. Since 2017, Acurx has been developing a new class of antibiotics to address the global crisis of antimicrobial resistance in Gram-positive bacteria. The goal is to replace decades-old antibiotics with a more effective drug able to overcome immune defense resistance. Moreover, its initial focus on treating CDI targets a billion-dollar market opportunity. Better still, it could be only one of several value drivers for the company this year. And with ACXP primarily targeting conditions with unmet medical needs, they could get help from regulatory agencies and grant funding to expedite trials.
By utilizing DNA polymerase IIIC inhibitors, Acurx is already positioning to deliver a first-line treatment to patients with C. difficile, a market that the CDC and CDI classify as an urgent threat requiring new antibiotic development. Moreover, the new drug could be the first to replace decades-old antibiotics with recurrent infection rates of between 20% - 40%. Its trial data to date is more than positive; it's compelling.
In fact, its Phase2a trial data using ibezapolstat in patients with CDI showed a 100% cure rate and 100% sustained clinical cure after 30 days of treatment. Better yet, ACXP believes that the results show an opportunity to leverage the drug applications to target other antibiotic development opportunities created by COVID-19. In fact, with policymakers worldwide intended to bring antibiotics' development back to the forefront, ACXP could be at the head of the line to benefit from that interest.
Specific to CDI, ACXP plans to replace the current standard of care that leaves a high burden of C. difficile in the gut, bettering their detrimental effect on the gut microbiome, leading to recurrence of CDI in up to 40% of patients once their therapy stops. ACXP's proposal appears to be a far better option.
And that puts billion-dollar markets in play.
Billion-Dollar Potential From CDI Market Alone
In fact, the CDI market is already a $1.295 billion opportunity. However, by 2026, the expectations are for that market to reach a more than $1.7 billion treatment opportunity.
Still, more than highly debilitating, CDI also brings a mortality rate of 9.3% and has a high level of recurrence. Thus, Acurx is more than timely; they are on track to get a potentially life-saving drug to market. As noted, its Phase2a results treating patients with mild to moderate CDI with orally administered ibezapolstat showed phenomenal results. In fact, all patients dosed with 450mg twice daily for 10 days contributed to ACRX meeting the study's primary and secondary efficacy endpoints of initial cure and sustained cure. Better still, the drug was well-tolerated, with no severe adverse reactions reported.
Investors shouldn't overlook that the trial results were impressive enough for regulators to allow for early termination of segment 2a and advancement to a Phase 2b trial. That next study arm is expected 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 if ibezapolstat can best the market leader, ACXP could be positioned to capitalize on several early opportunities, including substantial partnerships and licensing opportunity interests. Better still, with the treatment lasting only 10 days, investors could potentially get interim updates along the way.
Still, there's more to like in the pipeline.
High-Dollar Market Opportunities With ACX-375C
Also attracting investors' attention is its DNA PolIIIC inhibitor, ACX-375C, which targets severe infections, including Staphylococcus, Streptococcus, and Enterococcal infections. This drug may also be ideal for treating other G+ resistant bacterial infections, including VRE and MRSA, both highly debilitating and sometimes fatal infections.
The combined market potential exceeds billions and also taps into the need for substantially better treatment. Moreover, with MRSA accounting for more than 52% of infections in hospitalized patients, the need for an effective antibiotic is needed sooner rather than later. Even beyond treating MRSA and VRE, potential clinical indications include urinary tract, hospital-acquired catheter/bloodstream, bone/joint, pneumonia, and ear and sinus infections. Thus, ACX-375C has massive applications and multiple billion-dollar shots on revenue-generating goals. And like its treatments for the CDI markets, ACX-375C targets unmet medical needs to overcome antibiotic resistance in currently used treatments.
Better still, its antibiotic drug candidates will likely be eligible to earn Qualified Infectious Disease Product (QIDP) and Fast-Track designation. Also notable is that in a head-to-head comparison against Vancomycin, ibezapolstat showed itself as a better treatment option. In fact, unlike Vancomycin, ibezapolstat showed no reduction in healthy bacteria, was poorly soluble in the gut (a positive) and had free concentrations of ibezapolstat high enough to kill C. difficile but too low to kill healthy bacteria.
Thus, investors have every right to be optimistic about potential near and long-term value appreciation. And holding its 15% gains could be just the start.
Interest Drives Value Appreciation
Indeed, the strength of its IPO indicated that shares were met with extraordinarily high demand. In fact, its near 45% surge on that day may be the preview of more significant gains to come. After all, with only about 9.5 million shares in the float and several potential catalysts on deck, Acurx is indeed an attractive investment proposition.
Best of all, several of those catalysts could come sooner rather than later. In the near term, ACXP plans to file for QIDP designation for ACX-375C, start its Pre-IND Pharm/Tox studies for ACX-375C, file an IND, and seek fast-Track designation for ACX-375C as well. Thus, it may be wise for investors to watch the headlines.
Better still, it may be wise to position ahead of the news.
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