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INBS: Planned September 510(k) filing vs. dilution risk

T
Sep 4, 2026 · 17:10

My cost basis is around $24 and the stock is now around $2, so I’m down roughly 91%. I’m trying to figure out whether the story has actually improved or whether I’m just anchored to my entry price.

The good news: INBS reported 98.2% accuracy, 94.6% sensitivity and 100% specificity in its latest multi-site codeine study. Sensitivity was only about 82% in its previous study. The company says all data collection is complete and it expects to submit a new FDA 510(k) this month. FY2026 revenue also grew 38% to $4.2 million, with 502 active customers.

The concern is dilution. On September 2, INBS closed a $5 million private placement involving 2.04 million pre-funded warrants and two additional warrant series covering another 4.07 million shares. For comparison, the company had 3.03 million common shares outstanding as of August 18. It also used $11.9 million in operating cash during FY2026.

Do the improved study results materially increase the odds of 510(k) clearance? If it receives clearance for codeine, is that opportunity large enough to overcome the dilution and continued cash burn?

I’d appreciate actual bull and bear cases from anyone following it closely.

Sources: [September study and submission update](https://www.sec.gov/Archives/edgar/data/1725430/000149315226041055/ex99-1.htm) | [September financing](https://www.sec.gov/Archives/edgar/data/1725430/000149315226041253/form8-k.htm) | [FY2026 10-K](https://www.sec.gov/Archives/edgar/data/1725430/000149315226039136/form10-k.htm)