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CAMBRIDGE, Mass. - ProMIS Neurosciences Inc. (NASDAQ:PMN), a clinical-stage biotech company with a market capitalization of $28 million, announced Wednesday that its Data and Safety Monitoring Board has recommended proceeding to the third and final dose escalation cohort in its PRECISE-AD Phase 1b clinical trial of PMN310 for Alzheimer’s disease treatment. According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet.
The recommendation followed a safety data review through Cohort 2, which has been fully enrolled. No cases of amyloid-related imaging abnormalities (ARIA), a common side effect with similar treatments, have been observed to date. The company’s stock has shown significant price volatility, with shares trading between $0.38 and $1.59 over the past 52 weeks. Get deeper insights into PMN’s financial health and more exclusive ProTips with InvestingPro.
Enrollment for Cohort 3 has begun, with patients receiving the final 20 mg/kg dose level, up from 10 mg/kg in the second cohort. The trial is expected to enroll 128 patients total.
"The DSMB’s recommendation to proceed with the planned escalation to the final dose cohort underscores the steady progress of our Phase 1b program," said Neil Warma, President and CEO of ProMIS Neurosciences, according to the company’s press release.
PMN310 is designed to target toxic amyloid-beta oligomers while avoiding amyloid plaque, which the company believes may reduce side effects compared to other treatments. The antibody received FDA Fast Track designation in July 2025.
The trial remains on schedule to report 6-month interim data in the second quarter of 2026 and final 12-month top-line results in the fourth quarter of 2026. Analyst price targets for PMN range from $3.00 to $9.42, suggesting potential upside from current levels, though the company’s next earnings report is expected on November 12, 2025.
The PRECISE-AD study will evaluate multiple biomarkers, including pTau217, neurofilament light chain, and others to assess target engagement and potential disease-modifying effects.
Warma will present corporate updates at the H.C. Wainwright 27th Annual Global Investment Conference on September 10 in New York.
In other recent news, ProMIS Neurosciences has secured approximately $12 million in financing through a combination of private investment and warrant exercises. The company entered into a purchase agreement with existing institutional and accredited investors to issue and sell warrants totaling approximately $3 million. In a significant development, the U.S. Food and Drug Administration granted Fast Track designation to ProMIS’s lead Alzheimer’s disease therapeutic candidate, PMN310. This designation is intended to accelerate the development of therapies addressing serious conditions with unmet medical needs. Furthermore, ProMIS Neurosciences has mutually agreed with BTIG, LLC to terminate its At The Market Offering Agreement, which originally allowed the company to offer and sell up to $25 million of its common shares. Prior to the termination, 75,862 shares had been sold for gross proceeds of $190,274. The company also reported receiving Data and Safety Monitoring Board approval to escalate dosing in its Phase 1b clinical trial of PMN310. As of the latest update, no cases of amyloid-related imaging abnormalities have been observed during the trial.
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