Acurx Pharmaceuticals’ (NASDAQ: ACXP) earnings release is scheduled for Thursday, March 16, 2023. And like most biotechs, investors will be more focused on what the company says than what it posts. That’s typical. Clinical-stage drug development companies rarely post meaningful revenues. But, they provide guidance and clinical program updates, two areas where investors can appraise what the company is doing and where it’s going. Acurx Pharmaceuticals is expected to present plenty of each, and they could be milestones reached.
First, ACXP is expected to provide an exact number of patients enrolled in its Phase 2b trial. The better news could be that if data in this third set of patients confirms what was demonstrated during the first two-thirds of the study, ACXP could guide toward potential early termination of Phase 2b based on successful data and the urgency to get a better treatment to market. Shares could rally on that news.
Potential For Expedited Review Of Phase 2b Data
Another update could shed additional light on ACXP’s filing with the FDA to get an expedited review of its Phase 2b data. Giving that effort a push is an experienced and expert infectious disease team, which ACXP assembled as its “Independent Data Monitoring Committee” to look at the blinded data at 36 patients enrolled. Remember, an IDMC recommended early terminating its Phase 2a trial based on efficacy. If that is a precedent, ACXP could earn the same benefit, putting them on a direct path to its pivotal Phase 3 trial. Again, worthy of share price appreciation.
Biotech investors like to know if their investments are funded. ACXP is expected to update there as well. Details of the company’s efforts to secure CARB-X funding, including the potential dollars in play, would be welcomed news in ACXP’s mission to get its second antibiotic to the end of Phase 1 clinical trials. A final decision by Carb-X will be in April, which puts another catalyst, this time financial, in the crosshairs. Remember, because the funds are non-dilutive, they could add significantly to ACXP’s cash-per-share valuation. If funding scores over $10 million, it could justify a share price increase of $1.00 on a cash-to-shares consideration.
Updates On Non-Dilutive Funding Opportunities Expected
Other updates could provide insight into additional non-dilutive opportunities, progress in its secondary trials, and an update specific to revenue-generating opportunities in play from its ibezapolstat Phase 2b candidate treating C. difficile. Keep in mind Acurx Pharmaceuticals appears to be distancing itself from potential competitors. To date, Pfizer’s (NYSE: PFE) vaccine candidate PF-06425090, and the antibiotics cadazolid investigated by Johnson & Johnson (NYSE: JNJ) and surotomycin, investigated by Merck & Co (NYSE: MRK), failed to meet their primary endpoints. They are not the only ones falling short of expectations. Last year, Summit Therapeutics (NASDAQ: SMMT) decided to table the development of ridinilazole for pediatric C. diff. And in January of this year, Finch Therapeutics Group (NASDAQ: FNCH) halted its development of a fecal transplant technology for recurrent C. diff after failing to meet its intended objectives.
All told, ACXP may have quite a bit of good news in the queue, and Thursday could be the start of that feed. Stay tuned to its news channel here.
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