Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) stock is getting massive interest. Of course, the question is- why? Speculation is that its related to ACXP nearing a data release for its Phase 2b clinical trial targeting treatment for C. difficile, one of the most common causes of healthcare-associated infections in U.S. hospitals that is estimated to affect over 450,000 patients annually and, worse, is associated with approximately 20,000 deaths annually. That's just in the U.S. Using a global measure, that number gets a significant multiple.
But here's the bigger problem. Vancomycin, the current standard of care, has been shown to be relatively ineffective in stopping C. diff recurrence. But there could be excellent news on the way. Enter Acurx Pharmaceuticals.
They are advancing a drug candidate, ibezapolstat, through a Phase 2 clinical trial that is doing more than showing best-in-class treatment potential; it's also posting compelling evidence to fight recurrence all while several other drug candidates have failed.
Targeting Front-Line Designation To Treat C. diff
Those who have tried to achieve front-line therapy status but failed to successfully navigate the R&D gauntlet include Pfizer (NYSE: PFE), which missed meeting its primary endpoints in its Phase 3 CLOVER trial to treat C. diff. That miss added to the list of candidate failures from Sanofi (NYSE: SNY), which missed its endpoints back in 2017, and more recently, Summit Therapeutics (NYSE: SMMT), which published topline results that were far from impressive and missed their primary endpoint. Those three weren't the only ones disappointed to date. Another pharmaceutical company, Finch Therapeutics (NASDAQ: FNCH), recovered from a clinical hold setback in 2022 to post better results than the three listed, with 80.3% of trial participants receiving a single administration of its candidate following standard-of-care antibiotics achieved sustained clinical cure through eight weeks. Promising, yes. Better than ACXP? The data says NO.
Acurx published Phase 2a data that appears to be significantly better. The most significant advantage could be that compared to Finch's candidate, which focuses on the microbiome as a single dimension and has shown only a reduction in recurrent infection, ACXP's ibezapolstat is a dual-impact drug that addresses the direct infection and, to date, avoids recurrent infection altogether. Not only that, it restores the microbiome, a critical consideration. That difference alone supports a persuasive and data-driven argument that ACXP's ibezapolstat candidate is seemingly better than Finch's one-dimension drug in cases of multiple recurrent infections.
If that's the case, ACXP's candidate is on a better path to earning the preferred first-line treatment designation. Moreover, other than Finch', no other candidate looks close to emerging as a serious threat to ACXP's ibezapolstat's intended front-line position. Posters presented in September and October support that potential.
Highlights include ibezapolstat showing in-vitro potency, anti-virulence activities, high human fecal concentrations, 100% Clinical Cure rate in a 10-patient open-label trial, favorable safety profile to date, and potentially beneficial effects on the gut microbiome. That's not all. Ibezapolstat showed variable selectivity against Firmicutes, helping to elucidate its narrow spectrum of activity against certain pathogenic Firmicutes, including C. difficile. No other known drug, or the company behind it, has achieved similar positive data. That fact could be drawing interest. And plenty of it.
A Volume Surge In October
Some may be coming from partnership, licensing, or even a buyout interest. But the latter is doubtful, especially with an ACXP team that understands and can fully appraise the value inherent to its ibezapolstat candidate. Still, if the adage that "volume precedes price" is an indication, the path of least resistance for ACXP shares is higher.
Consider this: before October, the highest volume day for ACXP shares was 134,200, posted in July. Most days, less than 100k shares exchange hands. However, that all changed in October. Since its start, ACXP's lowest volume day was 367,300. But that's half of the story. The more compelling signal is that ACXP, on its highest days, scored volumes of 9.6 million, 7.7 million, 8.2 million, and 2.9 million, respectively. Keep in mind that at latest countACXP has only approximately 13.01million shares outstanding and a float of just 9.36 million. Calculating the remaining October trading days that posted volume above the 367k noted, ACXP stock has traded over 4X its entire float. No news was on the wires, and, no, ACXP is not part of any penny stock promotion. Instead, there is genuine interest. So much so that it sent ACXP stock to an intra-month high of $8.82, 488% higher from where it started the month. Currently, at $4.35*, the gains are holding an over 190% increase. (*share price at 11:36 AM EST, Yahoo! Finance)
Those speculating partnership could be right. And Pfizer could be the first to call. During its CLOVER trial update commentary, it expressed interest in pursuing the over one billion dollar market opportunity. Still, interest and ability are two different clinical beings, and in the drug industry, only the latter matters. That said, don't think PFE or any other Big Pharma player will be blinded by unwarranted optimism. In PFE's case, they know their candidate failed to meet endpoints. Moreover, they likely know, at best, its candidate, if approved, would be relegated to treating fringe and niche CDI treatment indications. Therefore, spending up to hundreds of millions of dollars more to advance an unpromising drug candidate makes little to no sense.
What does make sense is for deep-pocketed Big Pharma to cozy up with the presumed CDI treatment drug frontrunner. In this case, with data supporting the presumption, Acurx is the likely recipient of their first call. Remember that of late, what Big Pharma can't create, they acquire. And with ACXP showing evidentiary promise as one of the only companies left to bring an effective and comprehensive CDI treatment to market, it may be wise to consider a fair price for its lead asset.
Supporting An Appreciably Higher Market Cap
That price could support another ACXP price surge. Remember, the treatment potential from C. diff is estimated at over a billion dollars. That leaves ACXP stock potentially undervalued, in a big way, with its current market cap of roughly $56 million*. Strengthening that case is ibezapolstat's likelihood of earning front-line status, a proposition further supported by ACXP's CDI candidate demonstrating restoration of the patient's microbiome during treatment, which is highly unusual for an antibiotic. (* market cap on 10/26/23, Yahoo! Finance, 11:36 AM EST)
Remember this, too: Data from its Phase 2a trial was so impressive that it led the Trial Oversight Committee and the Scientific Advisory Board to allow for early termination of its Phase 2a trial and advance straight into a Phase 2b study. Furthermore, that jump was allowed after data on just ten patients showed a 100% cure rate and 100% sustained cure after follow-up. The better news is that Phase 2b was terminated early as well. And with the company planning to meet with the FDA to design a phase 3 trial, more likely than not, for excellent and similar reasons.
Justifying The October Volume Surge
Thus, plenty is offered for investors wanting reasons to support the massive surge in interest in ACXP stock. And all of it points to the likelihood that ACXP, the company, and its assets are in play. Know this also: the cost to partner with a Phase 2 company over a Phase 3 company can amount to hundreds of millions of dollars. Yes, hundreds of millions. Look at before and after market cap shots of companies making that leap. ACXP should be treated no differently.
In fact, its market cap can support a tripling in price. That's what an analyst at H.C. Wainwright expects, modeling a price target of $12.33 and a reiterated BUY rating in September. They may already see what others are just now starting to... Acurx is in the right place at the right time with the most promising CDI treatment drug to make a deal.
If so, whether in Phase 2 or planning its Phase 3, ACXP investors could be in for an exciting end to 2023. After all, whether ACXP goes it alone, takes a partner, or licenses ibezapolstat, the company appears to be playing a winning hand. And being able to see the cards being played, investors may want to back it.
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