ACHV Q2 earning: The thesis is still intact
ACHV reported earning early this morning.
Clinical stage company, so no revenue but the forward looking statements are promising.
If you recall, they received a CRL related to manufacturing. They have worked on this by getting a newmanufacturing partner. And are planning to resubmit new NDA in Q4 2026.
Aiming for potential FDA approval in H1 2027.
Key Numbers (Q2 ended June 30, 2026):
Net loss: $74.8 million ($0.80/share), vs. $12.7M prior year
Includes $48.7M non-cash charge from warrant liability fair-value change
Operating expenses: $18.4M
Cash & marketable securities: $187.3 million
Major Highlights:
Closed private placement of up to $354M ($180M upfront + up to $174M from milestone warrants tied to FDA approval of cytisinicline)
Proceeds to fund ORCA-V2 Phase 3 (vaping cessation), commercialization, and general corporate needs
Strengthened leadership (new CEO + commercial/CMC/quality hires) and Board
Investment thesis remains intact, the company focus is the NDA and the cash balance is removes runway risks..
Company Developing Smoking Cessation therapy, Millions of People in need.
The market is undervaluing this play because of regulatory delays. But the competitive moat is strong nonetheless.
