Joining me today is David Luci, President and Chief Executive Officer of Acurx, who will start by providing a corporate update and outlook. patents, along with patents in Israel, Japan, India, Australia, and Korea, all of which protect key aspects of the company's product pipeline. During the quarter, the company raised a total of approximately $3.1 million of gross proceeds through purchases under its equity line of credit. However, we're very excited to see that this new guidance explicitly states, and it now formalizes what had been published previously in the New England Journal of Medicine, but now specifically for C.
This new guidance refers back to a lineage of other FDA guidances going back to at least 2019, discussing the feasibility and the requirements for a single trial. What is very important is the new guidance, which is a final guidance, it's not a draft guidance, applies it specifically to C. I guess recurrent obviously it's recurring but treating the three at the end of the day, it's still sort of the same treatment, correct? The interesting thing about the new guidance is that for the first time, it talks about not just treatment and prevention of recurrence, it talks about long-term prevention of disease in a prophylactic fashion.
Certain bile acids are critical in actually suppressing the growth of C. those bacteria that are producing the bile acids that suppress the growth of C. Just quickly, you know, the FDA guidance also mentions or, like, emphasizes thoughtful selection of patient populations, especially when it comes to elderly populations. I was wondering if maybe you could talk to us about how your protocols also might align with this part of the guidance, this guidance as well.
| Metric | Period | Current guidance |
|---|---|---|
| Cash position | As of March 31, 2026 | $9.3M in cash (vs $7.6M at Dec 31, 2025) |
| April 2026 financing | Q2 2026 | Registered direct offering of 825,085 shares/pre-funded warrants at $3.03 plus short-term warrants for up to 1,650,170 shares at $2.78; registration statement now effective |
| rCDI exploratory trial start | ~August 2026 | In startup mode (site qualification); first patient targeted around August 2026 |
| FDA meeting on Phase 3 design | Summer 2026 | Scheduled to discuss applying the new one-trial standard and confirmatory evidence to ibezapolstat |
| Recurrence follow-up window | Phase 3 design | Patients to be followed ~8 weeks (two months) post-treatment, matching approved anti-recurrence agents (VOWST, Rebyota) |
| Metric | YoY | Note |
|---|---|---|
| Research & development expense (Q1) | $0.3M (vs $0.6M) | $0.1M lower manufacturing and $0.2M lower consulting as prior-year trial-preparation costs rolled off. |
| General & administrative expense (Q1) | $1.4M (vs $1.6M) | $0.1M lower professional fees and $0.1M lower legal costs. |
| Net loss (Q1) | $1.7M (vs $2.1M) | Continued low operating spend. |
| Diluted net loss per share (Q1) | $(0.62) (vs $(2.15)) | Smaller loss on ~3.39M shares outstanding. |
| Cash, equivalents & investments | $9.3M | ~$3.1M of ELOC proceeds in the quarter, ahead of the April registered direct offering. |
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| Regulatory pathway | One-trial standard proposed (NEJM) | FDA final guidance formalized for C. difficile; FDA meeting set for summer 2026 | Up |
| Funding / runway | $7.6M year-end cash | $9.3M cash plus April equity/warrant financing to fund the rCDI trial | Up |
| rCDI trial execution | Program announced | Site qualification underway; first patient ~August 2026 | Up |