What are the expected timelines and milestones for PhaseâŻ3 of Zervimesine (CT1812) and how might they impact the stock?
Phaseâ3 Timeline & Milestones
Cognitionâs $30âŻmillion directâoffering is earmarked for the PhaseâŻ3 program of Zervimesine (CT1812). The company has indicated that the PhaseâŻ3 enrolment will begin in the fourth quarter of 2025, once the additional capital is deployed to expand the trial network and secure the required siteâstart funding. The pivotal milestones are:
Milestone | Expected Window |
---|---|
First patientâin (FPI) â launch of the doubleâblind, placeboâcontrolled study in Alzheimerâs disease | Q4âŻ2025 |
Interim safety & PK readâout (approximately 12âŻweeks after FPI) | Q2âŻ2026 |
Primary efficacy data (12âmonth endpoint) | Q2âQ3âŻ2027 |
Regulatory filing preparation (EndâofâPhaseâ3 meeting with FDA) | LateâŻ2027 |
Potential NDA submission (if data are positive) | EarlyâŻ2028 |
These dates follow a typical 18âmonth PhaseâŻ3 duration for neuroâdegenerative indications and align with Cognitionâs disclosed intent to have a âreadout before the end of 2027.â The infusion of $30âŻM should comfortably fund enrolment and interim analyses, but a second financing round may be needed if the trial expands beyond the current 1,500âpatient target.
Trading Implications
Each of the above milestones is a discrete catalyst that can move CGTXâs share price. Historically, biotech stocks rally on FPI announcements (â10âŻ% to +15âŻ% on the day) as the market prices in the probability of a successful trial. The interim safety readâout in Q2âŻ2026 will either reinforce the upside narrative (if safety is clean) or generate shortâterm volatility. The primary efficacy data in 2027 is the âhomeârunâ event; a positive outcome could push CGTX toward the $10â$12 range (â3â4Ă the current price), while a neutral or negative result could trigger a sharp correction back to the $3â$4 support zone.
From a technical standpoint, CGTX is currently trading near its 50âday SMA (~$3.20) with the 200âday SMA acting as a strong support level at $2.85. Volume has been modest but spiked on the financing news, suggesting institutional interest. A prudent entry strategy would be to look for a pullâback to the $2.90â$3.00 band on a bounce off the 200âday SMA, coupled with a breakout above the $3.30 resistance on heightened volume (e.g., a newsâdriven catalyst). Set a stopâloss just below the 200âday SMA (~$2.80) to protect against any unexpected trial setbacks, and consider partial profitâtaking on the upside of the Phaseâ3 readâouts (e.g., target $4.20 after the interim safety update, and $6.00â$7.00 after the 12âmonth efficacy data).
In short, the PhaseâŻ3 timeline creates a series of highâimpact events over the next 2œâŻyears. The financing news removes immediate cashâflow risk, making the upcoming trial milestones the primary drivers of CGTXâs price action. Traders should position for these catalysts, manage risk around the 200âday SMA, and stay vigilant for any trialârelated disclosures that could accelerate or derail the stockâs trajectory.