Acurx Pharmaceuticals (NASDAQ: ACXP) IPO on Friday was a milestone reached. Priced at $6.00 per share, shares opened to strong investor interest that sent prices higher by more than 41% to $8.45 in late afternoon trade. Moreover, with only about 2.5 million shares in its float and enough capital to advance its ongoing trials, the company is ideally positioned to create substantial shareholder value going forward. Better still, with ACXP intending to deliver the first new class of antibiotics since the 1980s, that value could come sooner rather than later. (stock price comparison at 3:03 est 6/25/21)
Indeed, Acurx is well on its way to do just that. 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 quickly through pre-clinical development for potential new antibiotic candidates in scientific collaboration with WuXi AppTec and are 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.
The better news for investors is that ACXP is already expected to deliver potential catalysts before the end of this year. Thus, its rally could be just getting started. Better still, ACXP comes to market with a strong product pipeline and a management team capable of seeing its prospects to the finish line.
Evaluating Positive Data Treating Gram-Positive Bacteria
Keep in mind that while the IPO is just now bringing its stock to market, Acurx is not new to the clinic. In fact, since 2017, Acurx has been actively developing a new class of antibiotics to address the global crisis of antimicrobial resistance in Gram-positive bacteria. Even better, its initial focus on treating CDI could be the first of several value drivers for the company. And with ACXP primarily targeting conditions with unmet medical needs, there could be many to follow.
Better still, by utilizing DNA polymerase IIIC inhibitors, Acurx could have a first-line treatment available to patients with C. difficile to market sooner rather than later. Keep in mind, doing so would tap into a considerable market, with the CDC classifying CDI as an urgent threat requiring new antibiotic development. It would also give patients access to a potentially best-in-class treatment, replacing decades-old antibiotics with recurrent infection rates of between 20% - 40%. Already, the program is reporting extremely encouraging data.
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. To date, that efficacy profile is unmatched. 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 around the world intended to bring antibiotics' development back to the forefront, ACXP could be better positioned than most to capitalize from its new class of potential antibiotic treatments.
Keep in mind, too, that ACXP is looking to replace the current standard of care first-line that leaves a high burden of C. difficile in the gut. Moreover, their detrimental effect on the gut microbiome often leads to recurrence of CDI in up 40% of patients once their therapy stops. Hence, not only is Acurx focused on bringing a better option to market, but it can simultaneously meet an unmet medical need in the process.
And that puts billion-dollar markets in play.
Billion-Dollar Potential
In fact, the market in dollar terms is already a $1.295 billion opportunity. However, factoring in its 10% compounded annual growth rate, expectations are for that market to reach a more than $1.7 billion treatment opportunity by 2026. And patients need help.
More than highly debilitating, CDI also brings a mortality rate of 9.3% and has a high level of recurrence. Thus, Acurx could be on track to deliver a potentially life-saving drug to market. Already, 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. Best of all, the drug was well-tolerated, with no severe adverse reactions reported.
The results were so impressive that regulators allowed 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 a number of early opportunities, including substantial partnerships and licensing opportunity interests. Better still, with the treatment lasting only 10 days, investors should hear about results relatively soon.
And from a competitive perspective, its development program is patent-protected through 2032, along with 10 years of regulatory exclusivity from FDA approval. Thus, its value is well protected.
Still, there's more to like in the pipeline.
High-Dollar Market Opportunities With ACX-375C
Another program attracting investors' attention is its DNA PolIIIC inhibitor, ACX-375C, which targets severe infections, including Staphylococcus, Streptococcus, and Enterococcal infections. Moreover, the drug could be ideally positioned to treat 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. And with MRSA accounting for more than 52% of the infections in all hospitalized patients, having an effective drug 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. Also, this drug and program are protected by two patents covering composition of matter, formulation, and method of use that don't expire until 2039.
Better still, beyond its eligibility for Qualified Infectious Disease Product (QIDP) and Fast-Track designation, in a head-to-head comparison against Vancomycin, ibezapolstat showed itself to be 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 are right to bid shares higher. In fact, with at least two programs that bring multiple revenue-generating opportunities into focus, bullish sentiment is likely to continue.
A Breakout IPO
Indeed, the strength of trading on Friday showed that investors like the story. In fact, it's 32% run at press time indicates that investors believe the sum of the parts makes Acurx an attractive proposition. And with several catalysts expected during 2H 2021 and 1H 2022, they appear to be positioning ahead of those expected announcements.
Moreover, with ACXP planning 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, value-creating news could come soon.
Better still, with roughly $15 million in the bank following its IPO, ACXP won't be slowed in advancing its ambitious agenda. Best of all, with only about 2.5 million shares outstanding, ample cash on hand, and late-stage clinical programs that can be transformative to the antibiotics sector, Acurx is ideally positioned to create shareholder value in the days, weeks, and months ahead. And that agenda could be exposing a compelling investment opportunity.
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