INVESTMENT HIGHLIGHTS

AcurX Pharmaceuticals, Inc.  Snapshot

Stock Information

Price as of 10/27/21 $5.42
52 Week High – Low $3.71 – $8.74
Est. Shares Outstanding 10.12M
Market Capitalization $54.52M
Average Volume 86.92K
Exchange: NASDAQ

Acurx Pharmaceuticals, LLC, a clinical stage biopharmaceutical company, develops antibiotics to treat bacterial infections. Its lead antibiotic candidate is ibezapolstat, a novel mechanism of action that targets the polymerase IIIC enzyme that has completed Phase II clinical trial to treat patients with clostridium difficile infections. The is also developing ACX-375C, a potential oral and parenteral treatment targeting gram-positive bacteria, including methicillin-resistant staphylococcus aureus, vancomycin-resistant enterococcus, and penicillin-resistant streptococcus pneumoniae. The company was founded in 2017 and is based in Staten Island, New York.

Near-Term Catalysts

  • Acurx reported excellent add-on data from potentially transformational Ibezapolstat trial on 10/4/21
  • Phase 2a trial results show 100% cure and sustained cure
  • ACXP on track to deliver first meaningful advances to antibiotics market in over 40 years
  • Lead program targets C. difficile (CDI), a severe and debilitating condition with no current treatment able to effectively battle symptoms
  • Ibezapolstat trial data showing best-in-class treatment potential to treat gram-positive C. difficile
  • Platform targets gram-positive infections that represent a significant and often unmet medical need
  • AZRX putting ibezaplostat head to head against the current standard of care Vancomycin- putting a potentially enormous catalyst in play
  • Advancing pre-clinical program in a collaborative effort with WuXi App Tec evaluating the DNA Pol IIIC inhibitor to treat multiple infections, including Staphylococcus, Streptococcus, and Enterococcal infections
  • Received Health Holland $500,000 grant to Leiden Univ. Medical Center for collaborative study of the mechanism of action for DNA pol IIIC inhibitors
  • ACXP scalable platform puts multiple revenue-generating shots on treatment goals in play during the next 6-24 months.
  • Low O/S count of roughly 10.12 million shares combined with current share price allow for high-impact capital raises if needed
  • Provisional patent filed for use of ibezapolstat to treat C. difficile

Acurx Pharmaceuticals is in an exceptional position to capitalize on the phenomenal results from its Phase 2a segment of its C.difficile trial intending to bring meaningful change to the CDI treatment landscape. Its Phase 2b arm, which earned an early jump to Phase 2b from regulators, is evaluating ibezapolstat’s effectiveness in treating CDI, a debilitating, weakening infection with symptoms including severe diarrhea and life-threatening inflammation of the colon.

Interim data to date shows that ibezapolstat has the potential to become a best-in-class treatment after posting a 100% cure rate and 100% sustained clinical cure after 30 days of treatment. Results put ACXP in a position to bring to market an industry-changing antibiotic for the condition.

Near-term, ACXP intends to put its CDI treatment candidate against standard of care treatment Vancomycin. ACXP believes it can best that drug, which has historically shown a 40% chance of recurrence in patients once their treatment ends. Notably, Ibezapolstat doesn’t, putting ibezapolstat in a competitive position to potentially dethrone the current standard of care.

Moreover, with the trial relatively short in duration (6-10 weeks), a potentially massive value-creating event is in play possibly before the end of 2021. Positive data would likely help develop substantial strategic opportunities to monetize the asset sooner rather than later.

Acurx is also advancing a pre-clinical stage asset that shows potentially best-in-class attributes to treat several gram-positive infections. That platform showed early promise to counter numerous multi-drug resistant (MDR) and sensitive gram-positive bacterial pathogens. Called ACX-375C, the study intends to create a systemic Gram-positive selective spectrum (GPSS) bactericidal antibiotic.

The pre-clinical program is a collaborative effort with WuXi App Tec evaluating the DNA Pol IIIC inhibitor to treat multiple infections, including Staphylococcus, Streptococcus, and Enterococcal infections. Further, pre-clinical data to date suggest that ACX-375C can be effective against multiple gram-positive resistant bacterial infections and primary targets, MRSA and VRE, are in its crosshairs. Acurx believes its platform scalability could expand its candidate’s potential to treat numerous other infections, including more common indications such as ear and sinus infections, urinary tract infections, bone/joint infections, and pneumonia.

Positive updates from any of its trials, coupled with the slight competitive landscape, could have a substantial and positive effect on ACXP’s share price.

Competitive Analysis

From a competitive perspective, Acurx is positioned to become a market leader in its respected targeted indications based on already compelling data. They are also one of the few known clinical-stage companies willing to disrupt an antibiotics sector that has been distracted from developing treatments for gram-positive infections.

That situation also puts ACXP in a strong position to monetize its clinical assets through partnership and licensing opportunities. Strong Phase2a data already puts such a scenario in play. Further, as one of the few known clinical-stage companies accelerating a Phase 2 trial targeting C. diff, a market that has billion-dollar marketing potential, the interest from Big Pharma could come sooner than many expect.

Notable, too, investors should weigh AXCP’s pre-clinical program as a long-term value driver that could deliver near-term rewards. That program, which is getting substantial industry attention, also targets debilitating gram-positive infections. While investors should expect ACXP to grow into this opportunity by 2022-2023, interim updates could attract Big Pharma’s interest as well.

Catalyst Watch

For investors that seek opportunities to invest ahead of near-term milestones and catalysts, ACXP presents itself as a  compelling choice. They are leveraging outstanding Phase 2 data, are targeting antibiotics markets that are in dire need of better drugs, and are near to taking its drug candidate against the standard of care to treat C. difficile. Hence, several near-term catalysts could be near, especially with the duration of their trials typically measured in weeks, not years.

Even better, ACXP is developing a scalable platform, not just a single drug. That puts in play multiple shots on revenue-generating goals during the next 6-24 months. And with billion-dollar drug markets as the prize and with very little expected competition, it’s likely to see ACXP shares bid higher as the gets closer to Phase 3 studies.

Notably, ACXP provided clues to hearing about potential near-term value drivers. In queue could be interim data from its Phase 2b trial, filing for Fast Track and QIDP designations, and possibly additional earned grant funding adding to its $500,000 from Health Holland. Announcements on any of those could come in Q3 and Q4.

Further, if the results from its ongoing Phase 2b trial are as good as expected, the first leg higher toward a more appropriate valuation for a late-stage drug development may be near, possibly in as little to 3-6 months. Thus, ACXP is attractive from both a near and long-term investment perspective, offering investors an early stake in a potentially game-changing, industry-disrupting company.

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The Opportunity

ACXP brings investors multiple shots on revenue generating goals targeting a massive gram-positive infection treatment market. Near-term catalysts in play with updates from its Phase2b ibezapolstat trial as well as from its pre-clinical studies. Low O/S share count and float could help fuel a rally on expected positive news. Keeping in mind its 100% clinical cure and 100% sustained clinical cure rate after 30 days, ACXP is well-positioned to deliver on that front.
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