Also, in October, we were one of five companies to make a formal presentation at IDWeek in Atlanta at the session entitled New Antimicrobials in the Pipeline. Also presented were new colonic microbiome data from a state-of-the-art mouse infection model showing the potential microbiome-sparing class effect of representative compounds from our DNA Pol IIIc inhibitor preclinical pipeline.
Gary further stated, "These data indicate a low probability for DNA Pol IIIc inhibitors to increase the risk of causing a C. Now back to our CFO, Rob Shawah, to guide you through the highlights of our financial results for the full year and fourth quarter ended December 31, 2025.
The government apparently is looking for a new pipeline in that area. They'll probably, and we believe they're already working on a guidance for industry to clarify some of the questions and lay down the parameters for what that would be.
| Metric | Period | Current guidance |
|---|---|---|
| Cash position | As of Dec 31, 2025 | $7.6M in cash (vs $3.7M at Dec 31, 2024); ~$7-8M remaining on the ELOC |
| rCDI open-label pilot trial | 2026 | 20 patients (3+ prior episodes), 14-day treatment, 8-week primary endpoint, 6-month follow-up; ~$4-5M cost; first patient Q4 2026, full enrollment ~12-15 months later |
| rCDI Phase 3 registration trial | After pilot | Active-controlled pivotal trial (~360-400 patients) planned under the FDA Limited Population Pathway (LPAD) |
| Acute-CDI Phase 3 | Pending | Ready to advance internationally; ~474-patient non-inferiority design that may become a single pivotal trial under FDA's new one-trial standard |
| Full-year 2025 net loss | FY2025 | $8.0M (vs $14.1M in FY2024) |
| Metric | YoY | Note |
|---|---|---|
| Research & development expense (Q4 / FY) | Q4 $0.3M (vs $0.8M); FY $1.8M (vs $5.4M) | Lower manufacturing and consulting costs; prior year carried Phase 2b/Phase 3 preparation spend. |
| General & administrative expense (Q4 / FY) | Q4 $1.3M (vs $2.0M); FY $6.3M (vs $8.7M) | Lower professional fees, share-based compensation and compensation costs, partly offset by higher legal costs. |
| Net loss (Q4 / FY) | Q4 $1.6M (vs $2.8M); FY $8.0M (vs $14.1M) | Continued operating-cost discipline. |
| Diluted net loss per share (Q4) | $(0.73) (vs $(3.29)) | Smaller loss on ~2.35M shares outstanding at year-end. |
| Cash, equivalents & investments | $7.6M | ~$4M of full-year ELOC proceeds; ~$1.5M raised in Q4. |
| Topic | Previous mention | Current period | Trend |
|---|---|---|---|
| Clinical strategy | Acute-CDI Phase 3 focus | Added a recurrent-CDI (rCDI) program via LPAD - two shots on goal | Up |
| Regulatory environment | Two-trial standard | FDA moving toward a one-trial default that could apply to CDI | Up |
| Funding / manufacturing | Seeking a partner | U.S.-based manufacturing and stability supporting BARDA / stockpiling discussions | Steady |